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Background:In current drug safety education and training in Europe, an integrative and translational approach is lacking. This shortfall has been identified by EUFEPS. The IMI (‘Strategic Research Agenda’), the FDA and the EMEA have also characterised this fact as a crucial gap in the education and training of scientists evaluating the safety of drug candidates and new medicines.

Scope and objectives:We present a new and unique pan-European education and training network, which solves this shortfall by developing and establishing a comprehensive modular Education and Training Programme in Safety Sciences for Medicines (SafeSciMET). This programme will fulfil the needs of pharmaceutical industry, regulatory authorities and academia. The network, consisting of top institutes for drug safety education and research, proposes a new type, high quality and sustainable programme for education and training in Safety Sciences for Medicines (S2M). The tailor-made training modules will encompass the safety, ethical, regulatory and societal aspects in all phases of drug development, with emphasis on integrative, translational and 3Rs aspects of drug safety assessment. Individual safety professionals who wish to address specific knowledge gaps will be able to follow single modules. The modular set up also provides an excellent opportunity for following dedicated sub-sets of modules, to be accredited for Continuing Professional Development (CPD). Scientists successfully completing the full programme, including an integrative MSc-thesis, will be awarded with an accredited Master of Advanced Safety Sciences of Medicines (M4S2M). All training modules and procedures will be aligned with the Bologna process.

Principle learning outcomes are novel competences in translational safety sciences, leading to safety scientists who are able to perform holistic and critical evaluations of the safety of drug candidates and new medicines by linking of animal and patient data.